Novartis Pharma AG, Biologics Analytical Development, Lichtstrasse 35, CH-4056 Basel, Switzerland.
AstraZeneca, CMC Regulatory Affairs, 200 Orchard Ridge Drive, Gaithersburg, MD 20878, USA.
J Pharm Sci. 2024 Jun;113(6):1415-1425. doi: 10.1016/j.xphs.2024.02.010. Epub 2024 Feb 17.
The comparability assessment of a biological product after implementing a manufacturing process change should involve a risk-based approach. Process changes may occur at any stage of the product lifecycle: early development, clinical manufacture for pivotal trials, or post-approval. The risk of the change to impact product quality varies. The design of the comparability assessment should be adapted accordingly. A working group reviewed and consolidated industry approaches to assess comparability of traditional protein-based biological products during clinical development and post-approval. The insights compiled in this review article encompass topics such as a risk-evaluation strategy, the design of comparability studies, definition of assessment criteria for comparability, holistic evaluation of data, and the regulatory submission strategy. These practices can be leveraged across the industry to help companies in design and execution of comparability assessments, and to inform discussions with global regulators.
在实施生产工艺变更后，应对生物制品进行基于风险的可比性评估。工艺变更可能发生在产品生命周期的任何阶段：早期开发、关键试验的临床生产或批准后。变更对产品质量产生影响的风险不同。因此，应相应调整可比性评估的设计。一个工作组审查并整合了行业方法，以评估传统蛋白质生物制品在临床开发和批准后的可比性。本文综述了风险评估策略、可比性研究设计、可比性评估标准的定义、数据综合评估以及监管提交策略等方面的内容。这些实践可以在整个行业中加以利用，帮助企业进行可比性评估的设计和执行，并为与全球监管机构的讨论提供信息。
